NCT02735161

Brief Summary

The aims of the current study is to explore if different exercise training protocols affect fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

March 28, 2016

Last Update Submit

August 22, 2017

Conditions

SarcoidosisFatigue

Keywords

SarcoidosisFatigueExercise

Outcome Measures

Primary Outcomes (1)

  • Change in fatigue

    Changes of fatigue will be assessed assessed by Visual Analogue Scale (VAS), where the grade of fatigue is assessed between 0 (no fatigue) and 10 (maximal fatigue).

    Fatigue measured immediately before and acute after exercise sessions, (within 1 min.), and addition 24 hours post-exercise.

Secondary Outcomes (5)

  • Change in blood lactate

    Blood lactate are measured before and acute after exercise sessions (within 2 min.), and in addition 24 hours post-exercise.

  • Change in sarcoidosis related fatigue

    Measured first day and last day of a 4-week exercise based pulmonary rehabilitation

  • Change in metabolic and ventilatory variables from CPET

    Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation

  • Change in metabolic and ventilatory variables from CPET

    Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation

  • Change in maximal oxygen uptake

    Measured during a CPET first day and last day of a 4-week exercise based pulmonary rehabilitation

Study Arms (1)

Exercise training

EXPERIMENTAL

Four exercise training sessions. Two endurance training sessions, one with high intensity interval training and one session of moderate intensity of longer duration. Two strength training session; one with high load and few repetitions and one with low load and many repetitions. Fatigue and lactate will be measured before, after and 24 hours post-exercise. Trainings sessions will be randomized.

Other: Muscle strength trainingOther: Endurance exercise training

Interventions

Muscle strength trainingOTHER

Two different muscle strength training protocols will be compared; one exercise session with high load/low repetitions (4 sets x 5RM) versus one exercise session with low load/high repetitions (2 sets x 25RM). Both session will be conducted at four different exercises; seated leg press, chest press, cable lat pull down and seated rowing.

Exercise training
Endurance exercise trainingOTHER

Two different endurance exercise training protocols will be compared; one exercise sessions is interval training with high intensity (85-95% of HRmax) versus one of moderate intensity (70-75% of HRmax) with longer duration.

Exercise training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sarcoidosis diagnosed according to the latest American Thoracic Society/European Respiratory Society/World Association for Sarcoidosis and Other Granulomatous Disorders (ATS/ERS/WASOG) statement on sarcoidosis who are attending a four weeks exercise based pulmonary rehabilitation program at LHL-klinikkene Glittre.

You may not qualify if:

  • Patients with a concurrent and predominant diagnosis of another significant respiratory disorder (for example: asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, or lung cancer).
  • Unstable cardiovascular disease.
  • Not able to perform the required physical tests and exercise training sessions caused by co-morbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-klinikkene Glittre

Hakadal, 1485, Norway

Location

MeSH Terms

Conditions

SarcoidosisFatigueMotor Activity

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Siri Skumlien, PhD

    LHL Helse

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Out Patient and Laboratory Department, Researcher

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 12, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)